REACH RISK REDUCTION

Because of the many decisions regarding inclusion or exclusion of studies, different meta-analyses might reach very different conclusions on the same topic. Even after the studies are chosen, there are many other methodologic issues in choosing how to combine means and variances (e.g., what weighting methods should be used). Pooled analysis should report both relative risks and risk reductions as well as absolute risks and risk reductions (Sinclair and Bracken, 1994). 

For every endpoint investigated, the risk assessment for new substances assigns one of four available conclusions (i) the substance is of no immediate concern and need not be considered again until further information is made available in accordance with the requirements of Directive 67/548/EEC, (ii) the substance is of concern and the Competent Authority wiU define information required to refine the assessment and request that it is supplied when the quantity of the substance placed on the market reaches the next supply threshold, (iii) the substance is of concern and the Competent Authority wiU request that defined information is supplied without further delay, and (iv) the substance is of concern and the Competent Authority will immediately make recommendations for risk reduction. 

This principle is fundamental to numerous multilateral agreements and treaties. As mentioned in the conclusions quoted above, in order to make Precaution operational, pre-marketing measures ensuring the availability of an adequate set of information on the properties of chemicals are essential. Thus in order to be "safe instead of sorry" REACH establishes not only the "no data no market" approach but also an authorisation regime for substances of very high concern as they are representing serious hazards to human health and the environment. Particular inherent properties are directly linked to risk reduction measures - an unprecedented application of the Precautionary Principle. 

Human health and environmental exposure. The report concluded that "at present there is no need for further information and/or testing or for risk reduction measures beyond those which are being applied. This conclusion was reached because the risk assessment showed that risk reduction measures already being applied are considered sufficient [16]. 

A pooled analysis (52) of nine studies (NHS was divided into two studies) reached the following conclusion The results suggest a reduced incidence of major events at high supplemental vitamin C intakes. The risk reduction at high vitamin E or carotenoid intakes appear small. ... 

Review of RoSH published on 10 December 2008 will impose a review with REACH directive The risk assessment for short chain (C10—C13) chloroparaffins (SCCPs) was completed with the conclusion that the use of SCCPs in metal working and leather processing poses a risk to the aquatic environment. As a consequence, risk reduction measures have been implemented (EU Directive 2002/45). No significant risks to human health were identified. In all applications where they are used as flame retardants, no risk of secondary poisoning through accumulation in the environment or the food chain was found. Further studies of SCCPs have been specified by EU Regulation 642/2005 emissions and biodegradation in marine environment. 

The recommendations for chemicals prioritised for risk-reduction measures correspond to the current proposal for the new EU-legislation, REACH, and also to the environmental quality objective a Non Toxic Environment adopted by the Swedish parliament. The tool is also appreciated by companies and organisations outside Sweden, as a source of knowledge or inspiration. This tool may be used and further developed by Asian ASEM countries to suit their chemicals management needs. 

The restriction option has been considered to be a safety net (European Commission 2007) if other provisions in REACH or action under other laws are deemed to be insufficient. However, the Commission, the ECHA or member states are charged with the responsibility for preparing a restriction decision and must file a dossier clarifying the motives and the most appropriate risk reduction measures, after which a complicated decision-making process follows. The principal aspects here are more or less the same as for substances and decisions under the previous EC chemicals legislation.19... 

Moreover, some opinions issued by SCHER could, in our view, be interpreted as going beyond risk assessment, for example some conclusions reached on deca-BDE (a type of brominated flame retardant), which SCHER, after having criticised the Risk Assessment Report it reviewed, suggested should be the object of further risk reduction measures ... 

RRS = Risk-reduction strategy TGD = Technical guidance document [28] RIPs = REACH implementation projects... 

Chemical uses already specifically covered by product legislation Cosmetics construction products packaging plant protection products REACH should provide the mechanism to identify risks from substances not specifically covered by product legislation, e.g., environmental fate of cosmetic or emulsifiers used in plant protection products. However, in many cases other legislative frameworks may be more appropriate from devising and enacting the appropriate risk reduction measures. 

When it comes to decision-making regarding developing and selecting a risk reduction measure at the EU level... how is consensus reached between the Member States What do you see as the main obstacles and opportunities ... 

REACH-IT RIP RRS SAICM REACH-Information Technology REACH implementation project(s) Risk reduction strategy(ies) UNEP Strategic Approach to International Chemicals Management... 

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